Study Comparing Subcutaneous and Intravenous Paracetamol for Pain Relief in Adult Palliative Care Patients

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What is this study about?

This clinical trial focuses on patients receiving palliative care, which is a type of care aimed at providing relief from the symptoms and stress of a serious illness when the condition does not respond to curative treatment. The study is investigating the use of Paracetamol, a common pain reliever, administered in two different ways: subcutaneously (under the skin) and intravenously (through a vein). The purpose of the study is to understand how the body processes Paracetamol when given by these two methods in patients who are in palliative care.

Participants in the study will receive Paracetamol either under the skin or through a vein, and researchers will compare how the medication is absorbed and processed in the body. This will help determine the best way to administer Paracetamol to manage pain effectively in palliative care patients. The study will also monitor the patients’ pain levels using a simple numerical scale and check for any skin reactions or other side effects during the treatment period.

The trial will last for a period of up to 30 days, during which time the safety and effectiveness of the two methods of administering Paracetamol will be closely observed. The study aims to provide valuable information that could improve pain management for patients in palliative care, ensuring they receive the most effective and comfortable treatment possible.

1 joining the study

Upon joining the study, the patient will be required to sign an informed consent form. This confirms understanding and agreement to participate in the clinical trial.

The patient must be 18 years or older, undergoing palliative care, and able to communicate effectively. A functional central venous line is necessary, and the patient should experience spontaneous pain with a numerical scale greater than 3 or have paracetamol as part of their usual treatment.

2 initial assessment

A blood test must be conducted within 7 days prior to the start of the study to ensure there is no end-stage liver or kidney disease that would contraindicate the use of paracetamol.

The patient must not have any contraindications to paracetamol or other pain relief medications such as weak opioids, strong opioids, or NSAIDs.

3 medication administration

The study involves the administration of paracetamol in two different ways: subcutaneously and intravenously. The specific dosage is 10 mg/ml as a solution for infusion.

The patient will receive the medication according to the study protocol, and the administration will be monitored closely.

4 monitoring and assessment

Throughout the study, the patient’s pain levels will be assessed using a digital scale. This helps in understanding the effectiveness of the medication.

Skin monitoring and tolerance assessments will be conducted from the start of the study (D0) to the end (D30).

5 safety and follow-up

Any adverse events or side effects will be systematically collected and recorded from the time of consent signing to the end of the study period (D30).

The study aims to ensure the safety and well-being of the patient throughout the trial duration.

Who Can Join the Study?

Must be a hospitalized patient who is 18 years or older.
Must be receiving palliative care, which is care given to patients whose condition does not respond to treatment aimed at curing the disease.
Must be affiliated with the social security system.
Must have a functional central IV line (a type of tube placed in a large vein) with reflux, such as an implantable venous site, PICC line, or central line.
Must experience spontaneous pain (pain not related to medical care) with a pain score greater than 3 out of 10, or must have a prescription for paracetamol as part of their usual treatment.
Must be able to self-assess pain using a numerical scale.
Must have no contraindication (no medical reason to avoid) to taking paracetamol.
Must have no contraindication to taking other pain medications like weak opioids, strong opioids, or NSAIDs during the study.
Must have no medical reason to avoid stopping paracetamol 24 hours before the study starts, such as not having a fever.
Must have a recent blood test (less than 7 days old) showing no severe liver or kidney disease that would prevent taking paracetamol.
Must agree to participate in the study and sign an informed consent form.

Who Cannot Join the Study?

Patients who are not adults (under 18 years of age).
Patients who are not receiving palliative care. This means care aimed at improving the quality of life for patients with serious illnesses, rather than trying to cure the disease.
Patients who cannot communicate effectively.
Patients who do not have a functional central venous line. This is a special tube placed in a large vein to give medications or fluids.
Patients who do not experience spontaneous pain with a pain level greater than 3 on a numerical scale. This scale is used to measure pain intensity, where 0 means no pain and 10 means the worst possible pain.
Patients who do not use paracetamol as part of their usual treatment. Paracetamol is a common pain reliever and fever reducer.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Caen Normandie	Caen	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	02.09.2019

Trial locations

Investigated drugs:

Paracetamol

Paracetamol is a common medication used to relieve pain and reduce fever. In this clinical trial, it is being studied to understand how it behaves in the body when given in two different ways: under the skin (subcutaneously) and directly into a vein (intravenously). The goal is to see if there are any differences in how the body absorbs and processes the medication when given by these two methods, especially in patients who are receiving palliative care, which is specialized medical care for people with serious illnesses.

Chronic Pain – Chronic pain is a persistent pain that lasts for weeks, months, or even years. It can occur in any part of the body and may be constant or intermittent. The pain can be a result of an initial injury, such as a back sprain, or there may be an ongoing cause, such as illness. In some cases, there is no clear cause. Over time, chronic pain can lead to decreased mobility, flexibility, and strength, affecting daily activities. It often requires ongoing management to help individuals maintain their quality of life.

Trial ID:

2024-518795-31-00

Protocol code:

17-245

Trial Phase:

Therapeutic use (Phase IV)

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Study Comparing Subcutaneous and Intravenous Paracetamol for Pain Relief in Adult Palliative Care Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?